Kornimate/medical-research-clean huggingface dataset:
follow-up study of safety and efficacy in subjects who completed neurostem® phase-i/iia clinical trial.

Conditions: Alzheimer's Disease

Summary: a long-term follow-up study to obtain safety and efficacy data in subjects who completed phase 1/2a clinical trial of neurostem® (nct02054208), comparing neurostem and placebo groups for up to 36 months after the initial administration in patients suffering from alzheimer's disease

the subjects will be followed up at 12-month, 24-month, and 36-month (phone call) after the initial administration of neurostem®.

Eligibility criteria:
inclusion criteria: * assessment of safety and exploratory treatment efficacy in subjects who were enrolled and completed phase 1/2a clinical trial of neurostem®. * subjects who have been treated with either neurostem® or placebo at least 12 months ago. * subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial (in case it is difficult for the participant to sign, the consent of the legal representative) exclusion criteria: * subjects who were not enrolled in phase 1/2a clinical trial of neurostem® for assessing safety and exploratory treatment efficacy * other subjects, excluding those listed above, who were deemed unsuitable by the pi
risk of diabetes in young turner syndrome patients

Conditions: Turner Syndrome

Summary: turner syndrome is a common genetic disorder. seventy percent of adults with turner syndrome have abnormalities in glucose metabolism which can lead to diabetes. the current screening guidelines for diabetes in turner syndrome are not specific and involve a fasting blood sugar once a year. the objective of this study is to determine if there are abnormalities in glucose metabolism and pancreatic function in young girls with turner syndrome. the study hypothesis is that pancreatic dysfunction (specifically of the beta cells that make insulin) is more prevalent in girls with turner syndrome compared to healthy controls.

the study will be conducted at children's hospital medical center, cincinnati. the study will require 1 visit to the hospital where the subject will have an oral glucose tolerance test and a physical exam

Eligibility criteria:
turner syndrome females: inclusion criteria: * turner syndrome confirmed by chromosomal testing * on standard therapy (growth hormone and or estrogen) exclusion criteria: * type 1 or type 2 diabetes * polycystic ovarian syndrome * pregnancy * on any medications that alter blood sugar healthy female controls: inclusion criteria: * healthy exclusion criteria: * type 1 or type 2 diabetes * polycystic ovarian syndrome * pregnancy * on any medications that alter blood sugar

Keywords: turner syndrome diabetes
a study to evaluate the effects of renal function on pharmacokinetics and safety of da-8010

Conditions: Renal Impairment; Healthy

Summary: this study will evaluate the effects of renal function on pharmacokinetics and safety of da-8010


Eligibility criteria:
inclusion criteria: \[healthy volunteer\] * adult male or female, 19 years to 75 years * egfr ≥ 90 ml/min/1.73m\^2 * body weight over 45.0 kg and body mass index in the range of 18.0 to 40.0 kg/m\^2 * the subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate * the subjects who are judged appropriate to participate this clinical trial according to the physical examination, laboratory examination and questionnaire \[renal impairment patient\] * adult male of female, 19 years to 75 years * egfr \< 90 ml/min/1.73m\^2, not on dialysis * body weight over 45.0 kg and body mass index in the range of 18.0 to 40.0kg/m\^2 * the subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate * the subjects who are judged appropriate to participate this clinical trial according to the physical examination, laboratory examination and questionnaire exclusion criteria: * the subjects with acute illness * the subjects with a history of gastrointestinal disease or surgery that may affect the absorption of investigational product * the subjects hypersensitive to any of the investigational product components or other drug components * the subjects who have continuously consumed excessive smoking or alcohol within 6 months of screening, or who cannot stop smoking, caffeine, or alcohol intake during hospitalization * the subjects who have history of drug abuse * the subjects who are pregnant or lactating * the subjects who do not agree to exclude the possibility of pregnancy using the contraception from the date of the first administration of the investigational product until the 4 weeks after the last administration
ita - clinical study comparing arimidex™ with nolvadex™ in women with breast cancer treated with nolvadex for at least 2 years

Conditions: Breast Cancer

Summary: the purpose of this study was to assess the difference in disease-free survival between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued on tamoxifen.


Eligibility criteria:
inclusion criteria: * post-menopausal status; age ≤75 years; * histologically confirmed invasive breast cancer with metastases in the axillary lymph nodes; * oestrogen receptor status positive or unknown; * primary treatment (surgery +/- radiotherapy, +/- chemotherapy) completed exclusion criteria: * clinical evidence of metastatic disease (including local or remote recurrence, even if the patient appeared to be in complete remission at the time of randomisation).

Keywords: breast cancer
prosthetic rehabilitation of lip and palate deformaties in neonates using two different approaches

Conditions: Evaluation

Summary: this study was conducted to compare the use of conventional nasoalveolar molding appliances and the use of digitally designed and produced nasoalveolar molding appliances in rehabilitating neonates born with unilateral complete cleft lip and palate.

for this prospective study, twenty newborns with non-syndromic complete unilateral cleft lip and palate were referred from the outpatient clinics of several pediatric surgeons and obstetricians to the department of prosthodontics -faculty of dentistry - tanta university. inclusion criteria: * age range from 2-3 weeks after birth. * only the non-syndromic unilateral cleft lip and palate neonates. * newborn infants without any surgical intervention. exclusion criteria: * patients with the life threatening syndromes. * respiratory difficulties are not considered for presurgical treatment. * uncooperative guardians.

Eligibility criteria:
inclusion criteria: * age range from 2-3 weeks after birth. * only the non-syndromic unilateral cleft lip and palate neonates. * newborn infants without any surgical intervention. exclusion criteria: * patients with the life threatening syndromes. * respiratory difficulties are not considered for presurgical treatment. * uncooperative guardians.

Keywords: nasoalveolar molding digital nasoalveolar molding complete unilateral cleft lip and palate
quantitative liver functions in turner syndrome with and without hormone replacement therapy

Conditions: Turner Syndrome

Summary: several studies have demonstrated that turner syndrome patients have elevated liver enzymes readily suppressible by a short course of hrt. we wanted to estimated quantitative liver functions in a young group of turner syndrome patients compared to a healthy control group.

turner syndrome is due to the absence of a part of or the entire x chromosome in females. stature is short, and morbidity is increased due to risk of osteoporosis and fractures, type 2 diabetes, ischemic heart disease, hypertension, and stroke, but also the risk of cirrhosis is increased. clinical studies have shown a frequent occurrence of elevated liver enzymes, primarily alanine aminotransferase, g-glutamyl-transferase, and alkaline phosphatase, while bilirubin is normal. we and others have shown a normalizing effect of hormone replacement therapy (hrt), containing 17bestradiol and a gestagen, on liver enzymes, which may point towards a protective effect on hepatocyte integrity. marked architectural changes, including nodular regenerative hyperplasia, multiple focal nodular hyperplasia and cirrhosis are observed in some patients and are associated with a risk of liver-related complications. these changes are frequently associated with vascular disorders such as obliterative portal venopathy, probably related to congenitally abnormal vessels. steatosis, steatofibrosis, and steatohepatitis are seen and may be caused by metabolic disorders. in addition, bile duct alterations resembling small duct sclerosing cholangitis are observed in several patients. presently, it is not known whether these perturbations in liver morphology and in liver-derived enzymes are related to functional defects in females with ts and whether this may change by hrt. to further explore quantitative liver function in ts, we examined adult women with ts on and off hrt and compared them with a control group of age matched normal women. we used the galactose elimination capacity to assess hepatocyte cytosol activity, the plasma clearance of indocyanine green to assess hepatic blood flow and excretory liver cell function independently of hepatic blood flow, the antipyrine plasma clearance to estimate hepatic microsomal system activity, and the functional hepatic nitrogen clearance to assess mitochondrial- cytosolic metabolic capacity for conversion of amino-nitrogen.we assumed that one or more these metabolic liver functions would be diminished in untreated ts and normalized by hrt. our principal objective was to understand mechanistically how hrt improves liver function in ts.

Eligibility criteria:
inclusion criteria: * turner syndrome by karyotype exclusion criteria: * thyroid abnormality * glucocorticoid treatment

Keywords: ts hrt liver function tests
study of triostat in infants during heart surgery

Conditions: Heart Defects, Congenital

Summary: this is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine (triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease during cardiopulmonary bypass surgery.

patients will be randomized to receive study drug or placebo and randomization will occur stratified to each diagnostic category. all patients undergo preoperative echocardiograms to provide preoperative cardiac function data. the study drug or placebo will be provided in the operating room as an iv bolus just prior to cardiopulmonary bypass and as a bolus delivered on release of the aortic cross-clamp. this will be followed by iv for 12 hours. operative data will be collected including cpb time, aortic cross-clamp time, length and degree of hypothermia. these data will be extracted from the anesthesia record.

Eligibility criteria:
inclusion criteria: diagnosis of one of the following: * ventricular septal defect (vsd) * infant coarctation of the aorta * transposition of the great arteries * tetralogy of fallot * complete atrioventricular canal defect * hypoplastic left heart, including patients who undergo a norwood type procedure for aortic or mitral atresia patient must be scheduled for surgery. exclusion criteria: * certain additional defects and/or requirement for additional surgery.

Keywords: congenital heart defects hypoplastic left heart syndrome complete atrioventricular canal defect triostat cardiac surgery
randomized study of spinal anesthesia compared with traditional epidural anesthesia concerning peroperative and postoperative pain after open nephrectomy in patients with renal cell carcinoma

Conditions: Pre- and Postoperative Analgesia; Spinal Anesthesia; Renal Cell Carcinoma

Summary: the study aim to study whether spinal anesthesia (using: bupivacain, morfin och klonidin) can be better than epidural anesthesia during and after open surgery for renal cell carcinoma. per- and postoperative pain after spinal anesthesia with klonidin can be reduced and, thus, shorten the hospital stay and rehabilitation of the patients.


Eligibility criteria:
inclusion criteria: * all patients in asa score i - iii, planned to be treated with open radical nephrectomy or nephron-sparing surgery having renal cell carcinoma exclusion criteria: * patients in asa score iv-v, * patients with advanced tumour thrombus in vena cava inferior, * patients with high risk for bleeding * patients with previous chronic pain symptoms * patients having drug abuse * patients having cognitive deficiencies or dementia disease * patients with any contraindication of either spinal or epidural anesthesia * patients younger than 18 years and pregnant woman * patients having a weight less than 45 kg or weight over 120 kg

Keywords: spinal anesthesia epidural anesthesia klonidin renal cell carcinoma
phase ii study of s-488410 to treat non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the investigators identified three cancer-testis antigens, as targets for cancer vaccination against lung cancer. in this clinical study, the investigators examine using a combination of three peptides from these three antigens (s-488410) the safety, immunogenicity, and antitumor effect of vaccine treatment for advanced non-small cell lung cancer patients.

the purpose of this study is to evaluate the clinical efficacy and safety of s-488410 for advanced non-small cell lung cancers who failed to standard therapy. the investigators previously identified three novel hla-a\*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, as targets for cancer vaccination against lung cancer. in this phase ii trial, we examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for hla-a\*2402-positive advanced small cell lung cancer patients who failed to standard therapy.

Eligibility criteria:
inclusion criteria: * advanced nsclc that cannot undergo curative surgery. * patients that are refractory to standard chemotherapy or cannot be treated with further therapy due to severe adverse effects of chemotherapy. * histologically diagnosed nsclc. * clinical efficacy can be evaluated by radiologic methods within 4 weeks prior to receiving treatment. * ecog performance status 0-2 within 2 weeks prior to receiving treatment. * life expectancy \> 3 months. * age between 20 to 79 * male or female. * in patients or out patients. * able and willing to give valid written informed consent. exclusion criteria: * other malignancy requiring treatment * radiation, immunotherapy, hyperthermia, or surgery. * active and uncontrolled infectious disease * active and uncontrolled hepatic dysfunction, kidney dysfunction, cardiac disease, or lung disease (i.e. interstitial pneumonia). * autoimmune disease. * hiv-ab or antigen positive * prior anti-cancer therapy within 4 weeks * laboratory values as follows: 2000\ 5 x cutoff value, alanine transaminase \> 5 x cutoff value, total bilirubin \> 3 x cutoff value, and serum creatinine \> 3x cutoff value. * patients knows hla-a type. * breastfeeding and pregnancy (woman of child bearing potential) * refusal of pregnancy conception. * treated with s-488401, s-488402, or s-488403. * treated with other investigational drug within 3 months prior to receiving s-48810 treatment. * decision of nonenrollment of the patients by principal investigator or physician-in-charge from the view point of patient's safety.

Keywords: cancer vaccine hla-a*24:02 lung cancer ctl
long-term outcomes of isolated tricuspid valve surgery according to preoperative clinical and functional staging

Conditions: Tricuspid Regurgitation

Summary: tricuspid regurgitation (tr) was identified as an independent prognostic factor associated with excess mortality and morbidity, independent of left ventricular (lv) function and pulmonary hypertension. isolated tricuspid surgery has been performed for a long time in a few selected cases, however in recent years several studies have underlined how the poor outcomes described for isolated tricuspid valve surgery seem to be related to the baseline characteristics of the patients and to late referral for surgical treatment rather than the intervention itself. to facilitate patient screening, a new clinical and functional tr staging system has recently been proposed. this classification, which evaluates the progression of morphological variations of the tricuspid valve and right ventricle (rv) in association with the onset of symptoms, identifies several parameters and factors that can be useful for a better stratification of surgical risk. rather than simply assessing the degree of tr, this new staging mechanism also focuses on symptoms, rv remodeling and function, medical therapy, and right heart failure hospitalizations. investigators previously focused on the short-term (mainly hospital) outcomes of patients undergoing isolated surgery for severe tr, who were classified at baseline according to this clinical and functional staging system. results showed that a more comprehensive classification reflects the population and hospital outcomes of surgically treated patients with isolated tr. the purpose of this study is to ultimately evaluate long-term outcomes of this patients population and estimate the impact of baseline staging on long-term outcomes.


Eligibility criteria:
inclusion criteria: * adult patients * affected by severe tricuspid regurgitation (tr), both of degenerative and functional etiology and; * patients underwent isolated surgery, either repair or replacement, of the tricuspid valve * patients operated on at thecardiac surgery department of san raffaele hospital from may 2004 to may 2020. exclusion criteria: - patients with non-isolated tricuspid valve surgery (concomitant surgery on other valves).
effect of bilateral transversus thoracis muscle plane block in patients undergoing coronary artery bypass graft surgery.

Conditions: Coronary Artery Disease; Pain Syndrome

Summary: coronary artery bypass graft surgery is the standard surgical treatment for coronary disease. however, there is no consensus on analgesic management in patients undergoing cabg. the aim of the study is to evualuate efficacy of bilateral transversus thoracis muscle plane (ttmp) block combined with systemic analgesia, compared to systemic analgesia only, in patients undergoing elective on-pump cabg surgery. our main hypothesis is that a bilateral ttmp block performed after cabg surgery could reduce morphine consumption during the first 48 hours. the investigators conducted an age, gender and type of surgery-matched retrospective cohort study in the montpellier university hospital (france).


Eligibility criteria:
inclusion criteria: * to be over 18 * to be scheduled for cabg surgery in the center of the study during the study period. exclusion criteria: * chronic pain or opioid use before surgery * recent thoracic regional analgesia (\< 1 month) * preoperative dementia or other neurologic or psychiatric disease incompatible with vas pain scoring. * other technique of regional anesthesia (e.g. thoracic epidural) * opposition to data collection secondary exlusion criteria: * postoperative prolonged sedation in icu (\> 12 hours) * postoperative surgical complication requiring surgical revision during the first two days. * opposition to data collection expressed secondarily

Keywords: cardiac surgery coronary artery bypass graft surgery regional anesthesia transversus thoracis muscle plane block enhanced recovery after surgery pain, evaluated by visual analog scale score.
ocs-05 in patients with acute optic neuritis

Conditions: Optic Neuritis; Optic; Neuritis, with Demyelination

Summary: to evaluate the safety and tolerability of ocs-05 compared to placebo in patients with acute optic neuritis (aon) receiving the standard of care

acuity is a phase 2, multicentric, two-arm, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of ocs-05 compared to placebo in patients with acute optic neuritis (aon) receiving the standard of care. the study randomized 36 eligible patients aged between 18 to 60 with recent onset (visual loss symptoms) of unilateral acute optic neuritis with a demyelinating origin, of which 33 patients received ocs-05 2mg/kg/day, 3mg/kg/day or placebo for five days in addition corticosteroid standard of care (soc).

Eligibility criteria:
main inclusion criteria: * diagnosed with a unilateral acute optic neuritis with a demyelinating origin * onset of visual loss symptoms in the last 12 days before randomization main exclusion criteria: * optic neuropathy of non-demyelinating origin * known neuromyelitis optica with autoantibodies against aquaporin-4 (aqp4-abs) * patients with widespread and symmetric white matter alterations in the screening mri suggestive of other demyelinating disorders (e.g. metabolic disorders, mitochondrial disorders) * active, chronic disease (or stable but treated with immune therapy) of the immune system other than multiple sclerosis (ms) or myelin oligodendrocyte glycoprotein antibody associated disorder (mogad)(e.g. sjögren's disease, systemic lupus erythematosus) or with a known immunodeficiency syndrome (aids, hereditary immune deficiency, drug induced immune deficiency) * an alternative cause of visual loss (e.g. compressive or infiltrative lesion of the optic nerve, infections, genetic forms of visual loss. * diagnosed with macular edema, severe myopia (\>6 δ) or other disease of the retina at inclusion * known diabetic retinopathy * known glaucoma * female patients of child-bearing potential who are unwilling to use an effective contraception while enrolled on study and for the duration of the study. * male patients not willing to use contraception (abstinence, condom etc..) while enrolled in the study and receiving the experimental drug, and for at least 2 days after the last experimental drug administration. * breastfeeding or pregnant women

Keywords: acute optic neuritis (aon) demyelination optic neuritis
a trial on video-assisted thoracoscopic surgery and axillary thoracotomy for resection of early-stage non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this study is to establish the effects of vats lobectomy for early-stage non-small cell lung cancer. the aims of this study are: 1. to evaluate the early clinical benefits of vats lobectomy when compared with the axillary thoracotomy. 2. to evaluate the late effects of vats lobectomy on survival and quality of life when compared with axillary thoracotomy. 3. to establish the normative pattern of vats lobectomy for early-stage non-small cell lung cancer. 4. to explore the indication of vats lobectomy for the lung cancer.


Eligibility criteria:
inclusion criteria: * early stage nsclc and no metastasis of hilum of lung and mediastinum lymph nodes (short diameter ≤ 1 cm) on computed tomography (ct) scan; * no medical contraindications to lung resection * age ≤ 75 years old and ≥18 years old; * sign the informed consent form. exclusion criteria: * evidence of invasion into neighboring organs; * extensive pleura adhesion; * central lesion; * not suitable for single-lung ventilation; * had history of thoracotomy and radiation for thoracic region ; * pregnancy or lactation female patients; * cannot sign the informed consent form because of psychological, family and society factors; * had history of other malignant tumors within 5 years except for non-melanoma cutaneous cancer, uterine cervix cancer in situ and curative early-stage carcinoma of prostate; * participants can not accept operation for other uncontrolled factors.

Keywords: nsclc clinical early-stage